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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
US Army
Novartis
Express Scripts
Fuji
Baxter
QuintilesIMS
Johnson and Johnson
Medtronic

Generated: July 23, 2017

DrugPatentWatch Database Preview

GLAXOSMITHKLINE Company Profile

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What is the competitive landscape for GLAXOSMITHKLINE, and what generic alternatives to GLAXOSMITHKLINE drugs are available?

GLAXOSMITHKLINE has one hundred and fifty-eight approved drugs.

There are fifty-seven US patents protecting GLAXOSMITHKLINE drugs.

There are one thousand one hundred and eleven patent family members on GLAXOSMITHKLINE drugs in sixty-nine countries.

Summary for Applicant: GLAXOSMITHKLINE

Patents:57
Tradenames:113
Ingredients:95
NDAs:158
Drug Master File Entries: (click here to view)8
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 2009OTCYesYes8,501,164► SubscribeY ► Subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-005Apr 14, 2010ABRXYesNo9,144,547► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes7,498,440► SubscribeYY ► Subscribe
Glaxosmithkline
BEEPEN-VK
penicillin v potassium
TABLET;ORAL062273-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Glaxosmithkline
HISPRIL
diphenylpyraline hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL011945-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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Expired Patents for Glaxosmithkline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,596,260*PED► Subscribe
Glaxosmithkline
VENTOLIN
albuterol sulfate
SYRUP;ORAL019621-001Jun 10, 19874,594,359► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19985,856,355*PED► Subscribe
Glaxosmithkline
WELLBUTRIN SR
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020358-002Oct 4, 19965,427,798► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,532,246*PED► Subscribe
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Paragraph IV activity for GLAXOSMITHKLINE drugs

Drugname Dosage Strength Tradename Submissiondate
lamotrigine
Extended-release Tablets25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg
LAMICTAL XR
2/12/2014
nicotine polacrilex
Gum2 mg
NICORETTE
1/22/2013
nicotine polacrilex
Gum4 mg
NICORETTE
1/22/2013
dutasteride and tamsulosin hydrochloride
Capsule0.5 mg/0.4 mg
JALYN
10/26/2010
atovaquone and proguanil hydrochloride
Tablets62.5 mg/25 mg
MALARONE
9/14/2010
orlistat
Capsules60 mg
ALLI
9/8/2010
lamotrigine
Orally Disintegrating Tablets25 mg, 50 mg, 100 mg, and 200 mg
LAMICTAL ODT
12/21/2009
atovaquone
Oral Suspension750 mg/5 mL
MEPRON
10/20/2009
ropinirole hydrochloride
Extended-release Tablets6 mg
REQUIP XL
7/22/2009
atovaquone and proguanil hydrochloride
Tablets250 mg/100 mg
MALARONE
4/3/2009
ropinirole hydrochloride
Extended-release Tablets12 mg
REQUIP XL
2/5/2009
ropinirole hydrochloride*
Extended-release Tablets3 mg
REQUIP XL
1/8/2009
ropinirole hydrochloride
Extended-release Tablets3 mg
REQUIP XL
1/8/2009
ropinirole hydrochloride
Extended-release Tablets8 mg
REQUIP XL
11/3/2008
ropinirole hydrochloride
Extended-release Tablets4 mg
REQUIP XL
10/31/2008
ropinirole hydrochloride
Extended-release Tablets2 mg
REQUIP XL
10/14/2008
lamivudine
Tablets100 mg
EPIVIR-HBV
10/31/2007
ranitidine hydrochloride
Tablets150 mg
ZANTAC 150
10/30/2007
dutasteride
Capsules0.5 mg
AVODART
10/29/2007
propafenone
Extended-release Capsules325 mg
RYTHMOL SR
11/7/2006
propafenone hydrochloride
Extended-release Capsules225 mg and 425 mg
RYTHMOL SR
10/11/2006
sumatriptan succinate
Injection6 mg/0.5 mL, 0.5 mL (prefilled syringes)
IMITREX
5/9/2006
ropinirole hydrochloride
Tablets3 mg, 4 mg and 5 mg
REQUIP
2/4/2005
ropinirole hydrochloride
Tablets0.25 mg, 0.5 mg, 1 mg and 2 mg
REQUIP
12/22/2004
sumatriptan succinate
Injection6 mg/0.5 mL, 0.5 mL vials
IMITREX
10/25/2004

Non-Orange Book Patents for Glaxosmithkline

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,537,983 Anti-inflammatory androstane derivatives► Subscribe
7,125,985Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
8,853,404Muscarinic acetylcholine receptor antagonists► Subscribe
6,032,666 Inhalation device► Subscribe
8,658,200Flavoring of drug-containing chewing gums► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Glaxosmithkline Drugs

Country Document Number Estimated Expiration
African Regional IP Organization (ARIPO)1422► Subscribe
Germany60328883► Subscribe
Hong Kong1072206► Subscribe
Argentina002270► Subscribe
Canada2634715► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Glaxosmithkline Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0343Netherlands► Subscribe300343, 20210803, EXPIRES: 20230110
C/GB96/040United Kingdom► SubscribePRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
2014038,C1740177Lithuania► SubscribePRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
14/008Ireland► SubscribePRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
1740177/02Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Teva
Merck
Johnson and Johnson
Express Scripts
UBS
Dow
AstraZeneca
Federal Trade Commission
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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